Women who use the Mirena IUD may experience minor side effects such as irregular periods, nausea and headaches. These often go away within a few months of receiving Mirena. But, the birth control method can cause more serious side effects. These include perforation, device migration, pelvic inflammatory disease and ectopic pregnancy. Women may need surgery to remove the IUD in some cases.
Other side effects may last for years but are not cause for concern. For example, about 20 percent of women who use Mirena stop having their period after a year. When a woman stops using Mirena, her period usually comes back.
While rare, some women reported serious Mirena side effects. For example, ectopic pregnancy and infection are life-threatening side effects that require immediate treatment. In some cases, women may need to have surgery.
In Mirena lawsuits, women said the device caused migrated from its proper location and resulted in organ perforation and ectopic pregnancy.
“What side effects you experience really depends on how sensitive you are to man-made or synthetic progesterone hormones and that will be different from woman to woman.”
A July 16, 2018, search of the FDA Adverse Event Reporting System (FAERS) Public Dashboard showed the U.S. Food and Drug Administration received 91,265 reports of Mirena side effects from December 2000 to March 2018. A total of 37, 990 reports involved serious cases. That figure includes 131 cases of death.
About 2 million American women use Mirena, according to Bayer’s Mirena brochure dated July 2011. Bayer used the same figure in its July 2012 Mirena Welcome Kit. An estimate is not apparent in the company’s more recent promotional materials.
The majority of women experience mild side effects. These include minor pelvic pain or cramping after Mirena insertion. Many of these go away after a few months of using Mirena.
Some women experience hormonal side effects from Mirena. These occur when the body is getting used to the hormones in the IUD. These include bleeding, ovarian cysts and breast tenderness.
During the first three to six months after receiving Mirena, periods may be lighter or heavier. Then, they may stop altogether.
Bayer estimates that two out of 10 women who use Mirena will stop having their period after one year. Women should still see their doctor to rule out pregnancy.
If Mirena bleeding remains heavier than normal or becomes heavy after being light, women should call their doctor.
About 12 out of 100 women using Mirena develop cysts on their ovaries, according to the safety considerations on the Mirena website. Ovarian cysts happen when follicles on the ovary grow.
Most cysts go away on their own after one or two months, according to Bayer. But, if they cause pain a doctor may have to surgically remove them.
More than 5 percent of women who used Mirena in clinical trials reported breast pain or tenderness, according to the Mirena label. If pain is severe, women may see their doctor.
Device expulsion is the most reported Mirena side effect. It can happen any time after a doctor inserts Mirena.
Expulsion is when Mirena leaves its place in the uterus or falls out. A doctor can replace it after checking for pregnancy.
Women should contact their doctor immediately if they suspect Mirena is no longer in place.
Perforation occurs when the IUD cuts through the wall of the uterus. About one in 1,000 women with an IUD can suffer from perforation, according to a study published in the journal Contraception. Perforation can cause scarring or organ damage.
Perforation can happen during the insertion process or any time after. Perforation happens more often in women who are lactating or gave birth within six months of receiving Mirena, according to a 2012 study in RadioGraphics.
Mirena migration or displacement occurs when Mirena moves to another place in the body. This can happen after Mirena perforates the uterine wall and leaves the uterus.
Migration may lead to embedment. Embedment happens when the IUD gets stuck in other parts of the body. For example, in a 2016 issue of the International Journal of Surgery doctors reported a migration case. The IUD got stuck in the lining of the abdomen and required surgery to remove.
Less than 1 percent of Mirena users get a serious infection called pelvic inflammatory disease (PID). This condition requires immediate treatment. The highest risk of PID usually occurs within the first 20 days after Mirena insertion.
Rarely, a life-threatening infection called sepsis can occur a few days after Mirena insertion. Bayer said it received nine reports of sepsis since September 2006. Women with severe pain or unexplained fever should call their doctor immediately.
Over a five-year period, about eight in 1,000 women became pregnant while using Mirena, according to Bayer’s Mirena Welcome Kit. Pregnancy with Mirena can be life-threatening. It may also cause loss of fertility.
“In patients becoming pregnant with an IUD in place, septic abortion—with septicemia, septic shock, and death—may occur.”
A 2016 study in the International Journal of Women’s Health found that more women suffered ectopic pregnancies with hormone-releasing IUDs versus copper IUDs.
Ectopic pregnancy is when the fetus grows outside the uterus. The fetus usually grows in the fallopian tube. It is a life-threatening emergency.
Pseudotumor cerebri means “false brain tumor.” It is also known as intracranial hypertension. This condition mimics a brain tumor. It can happen at any time with Mirena.
A 2015 study in Therapeutic Advances in Drug Safety looked at FDA data. It found increased reporting of pseudotumor cerebri with Mirena.
If left untreated, the condition can cause permanent blindness. Treatments include weight loss, medication and surgery.
Please seek the advice of a medical professional before making health care decisions.
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